EFSA JournalPub Date : 2025-07-23DOI: 10.2903/j.efsa.2025.9548
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Matteo L. Innocenti, Jaume Galobart, Rosella Brozzi, Rafaella Christodoulou
{"title":"Assessment of the application for modification of the terms of the authorisation of the feed additive consisting of Weizmannia faecalis DSM 32016 (TechnoSpore50®) for all poultry species for fattening, reared for laying/breeding and ornamental birds (Biochem Zusatzstoffe Handels- und Produktionsges. mbH)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Matteo L. Innocenti, Jaume Galobart, Rosella Brozzi, Rafaella Christodoulou","doi":"10.2903/j.efsa.2025.9548","DOIUrl":"10.2903/j.efsa.2025.9548","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the additive consisting of <i>Weizmannia faecalis</i> DSM 32016 (TechnoSpore50®) as a zootechnical feed additive, for all poultry species for fattening, reared for breeding and laying and ornamental birds. The additive is already authorised for use in feed and water for drinking for the above-mentioned species. With this application, the company requested the modification of the current authorisations as regards the simultaneous use of the additive with the coccidiostats amprolium and narasin+nicarbazin. The FEEDAP Panel concluded that the proposed modification in the conditions of the authorisation would not modify the conclusions previously drawn regarding the safety of TechnoSpore50® for target species, consumers and the environment. Regarding user safety, the additive is not a skin/eye irritant but should be considered as a skin and respiratory sensitiser and inhalation and dermal exposure is considered a risk. In a former opinion, the compatibility of TechnoSpore50® with narasin+nicarbazin could not be established in an in vivo trial since the difference in colony counts of non-heat-treated caecal samples from the control group receiving only the additive and the respective treatment group receiving the additive and the coccidiostat was above 0.5 log. The applicant supplied a new in vivo trial suggesting that the microbiological method applied underestimated the counts of non-heat-treated samples since spores of <i>W. faecalis</i> DSM 32016 require a thermal treatment to germinate. Based on these findings, the Panel reconsidered the results of the in vivo trial formerly submitted and concluded that TechnoSpore50® is compatible to narasin+nicarbazin at the proposed conditions of use. TechnoSpore50® was found to be compatible with amprolium in an in vitro test.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9548","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144681067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-07-23DOI: 10.2903/j.efsa.2025.9563
European Food Safety Authority (EFSA), Vincenzo Cavalieri, Elisa Fasanelli, Giandomenico Furnari, Davide Gibin, Alicia Gutierrez Linares, Pierfederico La Notte, Luca Pasinato, Giuseppe Stancanelli
{"title":"Update of the Xylella spp. host plant database – Systematic literature search up to 31 December 2024","authors":"European Food Safety Authority (EFSA), Vincenzo Cavalieri, Elisa Fasanelli, Giandomenico Furnari, Davide Gibin, Alicia Gutierrez Linares, Pierfederico La Notte, Luca Pasinato, Giuseppe Stancanelli","doi":"10.2903/j.efsa.2025.9563","DOIUrl":"10.2903/j.efsa.2025.9563","url":null,"abstract":"<p>This scientific report provides an update of the <i>Xylella</i> spp. host plant database, aiming to provide information and scientific support to risk assessors, risk managers and researchers dealing with <i>Xylella</i> spp. Upon a mandate of the European Commission, EFSA created and regularly updates a database of host plant species of <i>Xylella</i> spp. The current mandate covers the period 2021–2026. This report is related to the twelfth version of the database published in Zenodo in the EFSA Knowledge Junction community, covering literature published from 1 July 2024 up to 31 December 2024 and recent Europhyt outbreak notifications. Informative data have been extracted from 41 selected publications. Fourteen new host plants were identified and added to the database. These plant species were naturally infected by <i>X. fastidiosa</i>, <i>X. fastidiosa</i> subsp. <i>multiplex</i> or <i>X. fastidiosa</i> subsp. <i>fastidiosa</i> in the United States, Italy, Portugal and Spain. No additional data were retrieved for <i>X. taiwanensis</i> and no additional multilocus sequence types (STs) were identified worldwide. New information on the tolerant/resistant response of plant species to <i>X. fastidiosa</i> infection were added to the database. The <i>Xylella</i> spp. host plant species were listed in different categories based on the number and type of detection methods applied for each finding. The overall number of <i>Xylella</i> spp. host plants determined with at least two different detection methods or positive with one method (between sequencing and pure culture isolation (category A)), reaches now 463 plant species, 210 genera and 71 families. Such numbers rise to 727 plant species, 319 genera and 91 families if considered regardless of the detection methods applied (category E).</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9563","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144687999","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-07-23DOI: 10.2903/j.efsa.2025.9591
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Nicole Bozzi Cionci, Jaume Galobart, Matteo L. Innocenti, Joana Revez
{"title":"Assessment of seven feed additives consisting of Lactiplantibacillus plantarum ATCC 55943, DSM 18112, DSM 18113, DSM 18114 and ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and ATCC PTA-6138, for all animal species (Pioneer Hi-Bred International, Inc.)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Nicole Bozzi Cionci, Jaume Galobart, Matteo L. Innocenti, Joana Revez","doi":"10.2903/j.efsa.2025.9591","DOIUrl":"10.2903/j.efsa.2025.9591","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the follow-up applications for renewal of seven technological additives, <i>Lactiplantibacillus plantarum</i> ATCC 55943, <i>L. plantarum</i> DSM 18112, <i>L. plantarum</i> DSM 18113, <i>L. plantarum</i> DSM 18114, <i>L. plantarum</i> ATCC 55944, <i>Lentilactobacillus buchneri</i> ATCC PTA-2494, <i>L. buchneri</i> ATCC PTA- 6138, as silage additives for all animal species. The additives are currently authorised. In the previous opinions, the FEEDAP Panel could not conclude on the full characterisation of the additives under assessment due to absence of data regarding the microbiological contamination and impurities. The applicant provided new data, which allowed the Panel to conclude on the characterisation of the products, and thereby its safety.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9591","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144681065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-07-22DOI: 10.2903/j.efsa.2025.9571
EFSA Panel on Plant Health (PLH), Antonio Vicent Civera, Paula Baptista, Anna Berlin, Elisavet Chatzivassiliou, Jaime Cubero, Nik Cunniffe, Eduardo de la Peña, Nicolas Desneux, Francesco Di Serio, Anna Filipiak, Beata Hasiów-Jaroszewska, Hervé Jactel, Blanca B. Landa, Lara Maistrello, David Makowski, Panagiotis Milonas, Nikos T. Papadopoulos, Roel Potting, Hanna Susi, Dirk Jan van Der Gaag, Andrea Battisti, Claude Bragard, Hugo Mas, Daniel Rigling, Massimo Faccoli, Alžběta Mikulová, Fabio Stergulc, Eugen Christoph, Olaf Mosbach-Schulz, Franz Streissl, Paolo Gonthier
{"title":"Commodity risk assessment of Acer plants from Ukraine","authors":"EFSA Panel on Plant Health (PLH), Antonio Vicent Civera, Paula Baptista, Anna Berlin, Elisavet Chatzivassiliou, Jaime Cubero, Nik Cunniffe, Eduardo de la Peña, Nicolas Desneux, Francesco Di Serio, Anna Filipiak, Beata Hasiów-Jaroszewska, Hervé Jactel, Blanca B. Landa, Lara Maistrello, David Makowski, Panagiotis Milonas, Nikos T. Papadopoulos, Roel Potting, Hanna Susi, Dirk Jan van Der Gaag, Andrea Battisti, Claude Bragard, Hugo Mas, Daniel Rigling, Massimo Faccoli, Alžběta Mikulová, Fabio Stergulc, Eugen Christoph, Olaf Mosbach-Schulz, Franz Streissl, Paolo Gonthier","doi":"10.2903/j.efsa.2025.9571","DOIUrl":"10.2903/j.efsa.2025.9571","url":null,"abstract":"<p>The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as ’High-risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by <i>Acer</i> plants (<i>A. griseum</i>, <i>A. platanoides, A. rubrum</i>, <i>A. saccharum, A. saccharinum</i>, <i>A</i>. <i>tataricum</i> and <i>A. tataricum</i> subsp. <i>ginnala, Acer</i> × <i>freemani</i>) imported from Ukraine as dormant plants: (a) 1–4 years old bare root plants and (b) 1–2 years old plants in pots, taking into account the available scientific information, including the technical information provided by Ukraine. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Two EU protected zone quarantine pests, i.e. <i>Cryphonectria parasitica</i>, and <i>Entoleuca mammata</i> and one EU-quarantine pest, i.e. <i>Lopholeucaspis japonica</i> fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures proposed in the technical dossier from Ukraine were evaluated taking into account the possible limiting factors. For the selected pests an expert judgement is given on the likelihood of pest freedom taking into consideration the distribution of the pest in Ukraine, risk mitigation measures acting on the pest and uncertainties associated with the assessment. The degree of pest freedom varies among the pests evaluated, with <i>L. japonica</i> being the pest most frequently expected on imported plants. The Expert Knowledge Elicitation (EKE) indicated with 95% certainty that between 9748 and 10,000 per 10,000 bare root 1–4 years old plants will be free from <i>L. japonica</i>.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9571","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144681431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-07-22DOI: 10.2903/j.efsa.2025.9580
EFSA Panel on Genetically Modified Organisms (GMO), Josep Casacuberta, Francisco Barro, Albert Braeuning, Ruud de Maagd, Michelle M. Epstein, Thomas Frenzel, Jean-Luc Gallois, Frits Koning, Antoine Messéan, F. Javier Moreno, Fabien Nogué, Giovanni Savoini, Alan H. Schulman, Christoph Tebbe, Eve Veromann, Tilemachos Goumperis, Paolo Lenzi, Ana M. Camargo, Pietro Piffanelli, Tommaso Raffaello
{"title":"Assessment of genetically modified cotton T304-40 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2024-23010)","authors":"EFSA Panel on Genetically Modified Organisms (GMO), Josep Casacuberta, Francisco Barro, Albert Braeuning, Ruud de Maagd, Michelle M. Epstein, Thomas Frenzel, Jean-Luc Gallois, Frits Koning, Antoine Messéan, F. Javier Moreno, Fabien Nogué, Giovanni Savoini, Alan H. Schulman, Christoph Tebbe, Eve Veromann, Tilemachos Goumperis, Paolo Lenzi, Ana M. Camargo, Pietro Piffanelli, Tommaso Raffaello","doi":"10.2903/j.efsa.2025.9580","DOIUrl":"10.2903/j.efsa.2025.9580","url":null,"abstract":"<p>Following the submission of dossier GMFF-2024-23010 Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect resistant and herbicide tolerant genetically modified cotton T304-40, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in cotton T304-40 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2024-23010 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton T304-40.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9580","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144681522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-07-22DOI: 10.2903/j.efsa.2025.p230701
{"title":"Plain Language Summary of the Updated consumer risk assessment of fluoride in food and drinking water","authors":"","doi":"10.2903/j.efsa.2025.p230701","DOIUrl":"10.2903/j.efsa.2025.p230701","url":null,"abstract":"","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.p230701","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144681521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-07-22DOI: 10.2903/j.efsa.2025.9478
EFSA Scientific Committee, Susanne Hougaard Bennekou, Ana Allende, Angela Bearth, Josep Casacuberta, Laurence Castle, Tamara Coja, Amélie Crépet, Ron Hoogenboom, Helle Knutsen, Claude Lambré, Søren Saxmose Nielsen, Dominique Turck, Antonio Vicent Civera, Roberto Villa, Holger Zorn, Jacqueline Castenmiller, Karlien Cheyns, Keyvin Darney, Mary Gilbert, Jean-Charles Leblanc, Haakon Meyer, Evangelia Ntzani, Martin Paparella, Marco Vinceti, Heather Wallace, Maria Anastassiadou, Maria Bastaki, Irene Cattaneo, Luna Greco, Anna Lanzoni, Francesca Riolo, Olaf Mosbach-Schulz, Andrea Terron, Thorhallur Halldorsson
{"title":"Updated consumer risk assessment of fluoride in food and drinking water including the contribution from other sources of oral exposure","authors":"EFSA Scientific Committee, Susanne Hougaard Bennekou, Ana Allende, Angela Bearth, Josep Casacuberta, Laurence Castle, Tamara Coja, Amélie Crépet, Ron Hoogenboom, Helle Knutsen, Claude Lambré, Søren Saxmose Nielsen, Dominique Turck, Antonio Vicent Civera, Roberto Villa, Holger Zorn, Jacqueline Castenmiller, Karlien Cheyns, Keyvin Darney, Mary Gilbert, Jean-Charles Leblanc, Haakon Meyer, Evangelia Ntzani, Martin Paparella, Marco Vinceti, Heather Wallace, Maria Anastassiadou, Maria Bastaki, Irene Cattaneo, Luna Greco, Anna Lanzoni, Francesca Riolo, Olaf Mosbach-Schulz, Andrea Terron, Thorhallur Halldorsson","doi":"10.2903/j.efsa.2025.9478","DOIUrl":"10.2903/j.efsa.2025.9478","url":null,"abstract":"<p>This updated risk assessment evaluated evidence on potential adverse health effects of fluoride related to all sources of oral exposure as mandated by the European Commission. Fluoride benefit assessment was not included. Effects on the central nervous system, thyroid and bone were prioritised. Evidence from human studies indicates that total fluoride intake is associated with adverse effects on the developing brain at drinking water concentrations > 1.5 mg/L. The evidence of such associations below 1.5 mg/L was not sufficiently consistent to draw conclusions for risk assessment. Using drinking water concentration of 1.5 mg/L as a reference point, a safe level of intake including all sources of oral exposure of 3.3 mg/day was established for pregnant women to protect the fetus. This safe level of intake was extended to apply to other adults and children > 8 years. It is considered protective also against possible adverse effects on thyroid function and bone mineralisation, for which associations have been observed at water concentrations > 1.5 mg/L. Dental fluorosis was considered the most sensitive endpoint for children ≤ 8 years. Tolerable upper intake levels (UL) of 1.0, 1.6 and 2.0 mg/day were established for infants, toddlers and children 4–8 years, respectively. These ULs are considered protective against other possible adverse effects of fluoride, including neurodevelopmental outcomes. Aggregate exposure included intake of fluoride from food, drinking water, discretionary salt and (ingested) dental care products. Aggregate exposure based on the mean concentration of fluoride in EU drinking water (submitted data) was below the above health-based guidance values (HBGVs) for all age groups. Aggregate exposure exceeds the HBGVs at the 95th percentile of intake in the scenario of the P95 concentration of fluoride in EU drinking water, for all age groups except adolescents. The risk assessment suggests that the current legal limit for drinking water (1.5 mg/L) in the EU is not sufficiently protective.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9478","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144681520","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-07-21DOI: 10.2903/j.efsa.2025.9529
EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize Solano, Henk Van Loveren, Laurence Vernis, Silvia Peluso, Magdalena Andryszkiewicz, Daniele Cavanna, Yi Liu
{"title":"Safety evaluation of the food enzyme α-amylase from the genetically modified Bacillus licheniformis strain DP-Dzb106","authors":"EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize Solano, Henk Van Loveren, Laurence Vernis, Silvia Peluso, Magdalena Andryszkiewicz, Daniele Cavanna, Yi Liu","doi":"10.2903/j.efsa.2025.9529","DOIUrl":"10.2903/j.efsa.2025.9529","url":null,"abstract":"<p>The food enzyme α-amylase (4-α-<span>d</span>-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified <i>Bacillus licheniformis</i> strain DP-Dzb106 by Genencor International B.V. The production strain met the requirements for the qualified presumption of safety (QPS). The food enzyme was considered free from viable cells of the production organism, but not from its DNA. It is intended to be used in three food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in two food manufacturing processes, dietary exposure was calculated only for the remaining one. It was estimated to be up to 2.084 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, the Panel considers toxicity tests unnecessary. A search for the homology of the amino acid sequence of the α-amylase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9529","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144666490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-07-17DOI: 10.2903/j.efsa.2025.9542
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Jaume Galobart, Matteo L. Innocenti, Maria Vittoria Vettori, Eleni Gkimprixi
{"title":"Safety and efficacy of a feed additive consisting of acacia gum (gum Arabic) for all animal species (A.I.P.G. Association for International Promotion of Gums)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Jaume Galobart, Matteo L. Innocenti, Maria Vittoria Vettori, Eleni Gkimprixi","doi":"10.2903/j.efsa.2025.9542","DOIUrl":"10.2903/j.efsa.2025.9542","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of acacia gum (gum Arabic) as a technological additive for all animal species. The FEEDAP Panel concluded that acacia gum does not raise concerns for genotoxicity and is considered safe for all animal species, at levels ranging 278–4889 mg/kg complete feed. Regarding the user safety, the additive was considered a potential dermal and respiratory sensitiser, and any exposure by dermal or inhalation routes is considered a risk. The Panel concluded that the additive is efficacious as an emulsifier and in stabilising emulsions over time, which would support its efficacy as a stabiliser.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9542","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144647223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-07-16DOI: 10.2903/j.efsa.2025.9531
EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize de Lourdes Marzo Solano, Henk Van Loveren, Laurence Vernis, Laura Sanmartín Cabo, Yi Liu
{"title":"Safety evaluation of the food enzyme α-amylase from the genetically modified Bacillus licheniformis strain DP-Dzb105","authors":"EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize de Lourdes Marzo Solano, Henk Van Loveren, Laurence Vernis, Laura Sanmartín Cabo, Yi Liu","doi":"10.2903/j.efsa.2025.9531","DOIUrl":"10.2903/j.efsa.2025.9531","url":null,"abstract":"<p>The food enzyme α-amylase (4-α-<span>d</span>-glucan glucanohydrolase, EC 3.2.1.1) is produced with the genetically modified <i>Bacillus licheniformis</i> strain DP-Dzb105 by Genencor International B.V. The production strain met the requirements for the qualified presumption of safety (QPS). The food enzyme was considered free from viable cells of the production organism, but not from its DNA. It is intended to be used in two food manufacturing processes. Since residual amounts of food enzyme-total organic solids are removed in these two processes, dietary exposure was not calculated. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, the Panel considered toxicity tests unnecessary. A search for the homology of the amino acid sequence of the α-amylase to known allergens was made and matches with one respiratory allergen and one contact allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9531","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144635428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}